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Transcranial Magnetic Stimulation (TMS) in Binge Eating Disorder (BED) (TMS&BED)

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ClinicalTrials.gov Identifier: NCT03540641
Recruitment Status : Recruiting
First Posted : May 30, 2018
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Julian Reyes López, Universidad Autonoma de Queretaro

Brief Summary:
This study evaluates de efficacy of 5Hz repetitive Transcranial Magnetic Stimulation (rTMS) applied on the left dorsolateral prefrontal cortex in patients with binge eating disorder.

Condition or disease Intervention/treatment Phase
Binge-Eating Disorder Device: MagVenture MagPro R30 Not Applicable

Detailed Description:
Binge Eating Disorder (BED) affects a significant percentage of de national population (1.4%) in a portio 2-1 in woman compared with men, the repetitive Transcranial Magnetic Stimulation (rTMS) is a neuromodulation technique, which allows us to induce brain electrical activity by plating magnetic fields and it has been proven that at 10Hz it has an effect of improvement in the craving of food.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of the Transcranial Magnetic Stimulation Applied on the Left Dorsolateral Prefrontal Cortex on the Clinical and Neuropsychological Variables in Subjects With Binge Eating Disorder
Actual Study Start Date : April 6, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
Active Comparator: 1500 pulses
This group will receive 1500 pulses of transcranial magnetic stimulation at 5Hz over the left dorsolateral prefrontal cortex, until completing 15 sessions
Device: MagVenture MagPro R30
the subjects will receive 1500 or 5000 pulses at 5Hz
Other Name: repetitive Transcranial Magnetic Stimulation

Sham Comparator: 1500 pulses sham
this group will receive the sham modality of the protocol of 1500 pulses at 5Hz of transcranial magnetic stimulation during 15 sessions.
Device: MagVenture MagPro R30
the subjects will receive 1500 or 5000 pulses at 5Hz
Other Name: repetitive Transcranial Magnetic Stimulation

Active Comparator: 5000 pulses
This group will receive 5000 pulses of transcranial magnetic stimulation at 5Hz over the left dorsolateral prefrontal cortex, until completing 15 sessions.
Device: MagVenture MagPro R30
the subjects will receive 1500 or 5000 pulses at 5Hz
Other Name: repetitive Transcranial Magnetic Stimulation

Sham Comparator: 5000 pulses sham
this group will receive the sham modality of the protocol of 5000 pulses at 5Hz of transcranial magnetic stimulation during 15 sessions.
Device: MagVenture MagPro R30
the subjects will receive 1500 or 5000 pulses at 5Hz
Other Name: repetitive Transcranial Magnetic Stimulation




Primary Outcome Measures :
  1. Food Craving Inventory (FCI) [ Time Frame: 6 weeks ]
    The FCI is a self-report inventory designed to measure the food craving, is made up of 37 elements and is a scale-likert instrument.


Secondary Outcome Measures :
  1. Barratt Impulsivity Scale (BIS-11) [ Time Frame: 6 weeks ]
    The Barratt Impulsiveness Scale is a questionnaire designed to assess the personality / behavioral construct of impulsiveness is composed of 30 items describing common impulsive or non-impulsive (for reversed scored items) behaviors and preferences .



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects of both sexes.
  2. Subjects from 18 to 45 years of age.
  3. Subjects with diagnosis of binge eating disorder.
  4. Subjects without changes in pharmacological treatment in the last 30 days.
  5. Subjects who agree to sign the informed consent letter.

Exclusion Criteria:

1.Subjects with a history of traumatic brain injury with loss of consciousness. 2.Subjects with intracranial metallic objects or metal plates in the skull.

3.Subjects who suffer chronic diseases not controlled at the time of entering the study (for example: hypertension, diabetes, rheumatic diseases).

4.Patients with psychotic symptoms, bipolar affective disorders and substance dependence.

5.Subjects with alterations in electroencephalogram (epileptiform activity). 6.Patients with any type of chronic or neurological medical disease not controlled.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03540641


Contacts
Contact: Sofia Cañizares, nutriologist (442)1910317 soficanizares@gmail.com

Locations
Mexico
Sofía Cañizares Gómez. Recruiting
Querétaro City, Querétaro, Mexico, 76170
Contact: Sofia Cañizares, Nutriologist    005214421910317    soficanizares@gmail.com   
Sponsors and Collaborators
Universidad Autonoma de Queretaro
Investigators
Study Director: Julian Reyes López, Doctor Universidad Autónoma de Querétaro

Publications of Results:

Responsible Party: Dr. Julian Reyes López, professor, Universidad Autonoma de Queretaro
ClinicalTrials.gov Identifier: NCT03540641     History of Changes
Other Study ID Numbers: 9320
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Julian Reyes López, Universidad Autonoma de Queretaro:
Binge Eating Disorder
Transcranial Magnetic Stimulation
Food Craving

Additional relevant MeSH terms:
Disease
Feeding and Eating Disorders
Binge-Eating Disorder
Bulimia
Pathologic Processes
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms